Upon receipt of the Request for Approval, the Office of Human Subject Research Protection (HSRP) conducts a preliminary review. Investigators are responsible for allowing a minimum of 30 business days for the review process. (This means that you should apply at least 5 weeks before your anticipated start date.)
When necessary, investigators will be asked to provide additional information, clarification, or modifications. To prevent unnecessary delays, investigators are encouraged to follow the application instructions carefully on their initial submission and to provide any requested information as soon as possible. If follow-up communication is not received within 60 days, HSRP will request documentation of the status of the study and/or consider the application withdrawn. The IRB considers only specific and well-defined proposals; it does not give blanket authorization for broad or undefined topic areas.
As part of the initial review, HSRP assigns protocols to Exempt, Expedited Review or Full Committee Review status. The level of potential risk to the research participant determines the classification. Research categorized as Exempt or Expedited involves less than minimal risk or minimal risk, respectively, to the participant. Studies involving more than minimal risk require review by the full IRB. Final determination of Exempt, Expedited and Full Committee Status is made the IRB.
“Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” 46.102(i)
For studies categorized as Exempt or Expedited [46.110]
Once the initial review is complete and the application is in satisfactory form, it is forwarded to the IRB chairperson for consideration of approval. If the Chair determines that the protocol can be approved as written, he will sign an approval. HSRP will send written notification of approval to the investigator. If a signed Informed Consent or Informed Consent and Health Information Use and Disclosure Authorization is required from participants, HSRP will stamp the approved document. This stamped document is to be copied and provided to participants for signature. HSRP will also stamp any approved recruitment materials. If the Chair has any concerns or requests, HSRP will contact the investigator to provide the necessary information or to make the modifications.
For projects requiring Full Committee Review [46.109]
The application will undergo initial review as described above. Once the proposal package is complete with any requested amendments or additions, HSRP will contact the investigator to set a date for review by the Institutional Review Board (IRB). The presence of the PI is requested at the meeting to discuss issues relevant to the protection of the research participants. Investigators are also requested to provide HSRP with sufficient copies of the protocol so IRB members may review the proposed research two weeks prior to the meeting. IRB meetings are held monthly and the meeting schedule is posted on the HSRP website. (NU IRB Meeting Schedule)
The NU IRB meets monthly to review protocols. Depending upon the nature of the research, some studies may be reviewed and approved independently by the Chair of the NU IRB. Other studies may require review by the full committee.
At the IRB meeting
The PI may present a very brief overview of the research. Committee members will use this opportunity to ask the PI questions to clarify or explain any issues that are unclear or about which they may have some concern. Members may discuss with the investigator procedures that will promote protection for the confidentiality or welfare of participants. The PI will then leave to allow private discussion by the members.
Following discussion and resolution of any issues, the Board will take one of three actions:
- The Board may approve the proposal as written. If so, the PI will receive written notice of approval from HSRP.
- The Board may require the PI to amend the protocol, including consent forms, recruitment materials, study instruments or provide additional information. If such materials are required, the Board will designate whether these amendments may be reviewed and approved by the IRB Chairperson, or reviewed by the full committee at the next scheduled meeting.
- The IRB also has the authority to disapprove research activities. The Board will provide written notification to the principal investigator of the decision. It will also include a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
All IRB actions should be communicated to the PI within one week of the meeting.
Approvals by IRB apply to use of human subjects only. University officials may require reviews and approvals for other reasons. However, no university official may approve research that has not been approved by the IRB. [cfr46.112]
Time Frame for Review
It is the investigator’s responsibility to allow sufficient time for the IRB approval process. Submission should be early if the researcher has deadlines for grant submissions, start dates for studies, etc. Investigators are responsible for allowing a minimum of 30 business days for the review process. (This means that you should apply at least 5 weeks before your anticipated start date.) Protocols are reviewed in the order in which they are received.
Factors that affect the time frame necessary for review include:
- The completeness of the initial submission
- Review category, e.g., exempt status versus full committee review
- Number of protocols currently under active review by HSRP
- Response time by investigators to provide requested information or amendments
- Potential wait for IRB approvals or letters of permission from related sites